A Multicenter, Randomized, Open-Label, Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-306 vs. Salvage Chemotherapy Regimens in Patients With IDH1- and IDH2-mutated Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Status: Recruiting
Location: See all (53) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is a multicenter, randomized, open-label, phase III clinical study (RAPHAEL) to evaluate the efficacy, safety, and PK of HMPL-306 versus salvage chemotherapy in patients with R/R AML harboring IDH1 and IDH2 mutations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Have signed the ICF;

• Be able to follow the requirements of study protocol;

• Age ≥18 years;

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2;

• Cohort 1: Patients with R/R primary AML harboring IDH1-R132 site mutation \[WHO 2022 Classification Criteria for Myeloid Neoplasms and Acute Leukemia, with the exception of APL (AML-M3) and extramedullary recurrence of leukemia alone without bone marrow involvement\]; Cohort 2: Patients with R/R primary AML harboring IDH2-R140/R172 mutations \[WHO 2022 Classification Criteria for Myeloid Neoplasms and Acute Leukemia, with the exception of APL (AML-M3) and recurrence of extramedullary leukemia alone without bone marrow involvement\]. A patient with both IDH1 and IDH2 mutations will be included in Cohort 2 (IDH2 mutation group);

• Agree to undergo bone marrow aspiration and/or biopsy before and during treatment;

• Be willing to complete QoL assessments at specified time points during study treatment and after treatment discontinuation;

• Female patients of childbearing potential must agree to use highly effective contraceptive methods during the study and within 30 days after discontinuation of the study drug (the time limit of contraception for the chemotherapy group needs to be extended to 6 months after the last dose) (see Appendix 9 (contraception requirements) for more information), and agree not to donate eggs (oocytes) for reproductive purposes during this period; patients must not be lactating and must have a negative pregnancy test (if of childbearing potential);

• Male patients with female partners of childbearing potential must use condoms during intercourse and avoid donating or freezing sperm during the study and within 30 days after discontinuation of the study drug (the time limit of contraception for the chemotherapy group needs to be extended to 6 months after the last dose).

⁃ Predicted survival greater than 12 weeks as assessed by the investigator.

Locations
Other Locations
China
Baoding NO.1 Central Hospital
RECRUITING
Baoding
Peking University People's Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
People's Hospital of Hunan Province
RECRUITING
Changsha
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Xiangya Hospital Central South University
RECRUITING
Changsha
Affiliated Hospital of Chengde Medical University
RECRUITING
Chengde
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
The First Affilated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Guangzhou First People's Hospital
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Nanfang Hospital,Southern Medical University
RECRUITING
Guanzhou
Guizhou Provincial People's Hospital
RECRUITING
Guiyang
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
The First Affiliated Hospital, Zhejiang University
RECRUITING
Hangzhou
Harbin First Hospital
RECRUITING
Harbin
Anhui Provincial Hospital(The First Affiliated Hospital of U STC)
RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The Second Hospital of Anhui Medical University
RECRUITING
Hefei
Qilu Hospital of Shandong University
RECRUITING
Jinan
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The First People's Hospital of Yunnan Province
RECRUITING
Kunming
The First Affilated Hospital of Henan University of Science & Technology
RECRUITING
Luoyang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Quanzhou First Hospital Affiliated to Fujian Medical University
RECRUITING
Quanzhou
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Tongji Hospital of Tongji University
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
The First Hospital of China Medical University
RECRUITING
Shenyang
Shenzhen Second People's Hospital
RECRUITING
Shenzhen
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
RECRUITING
Tianjin
Tianjin People's Hospital
RECRUITING
Tianjin
XinjiangUiger Municipal People's Hospital
RECRUITING
Ürümqi
The First Affiliated Hospital of WMU
RECRUITING
Wenzhou
Wuhan Union Hospital of China
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Wuxi People's Hospital
RECRUITING
Wuxi
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hosiptal)
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
The second people's hospital of Yibin
RECRUITING
Yibin
Affiliated Hospital of Guangdong Medical University
RECRUITING
Zhanjiang
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Affiliated Hospital of Zunyi Medical Univercity
RECRUITING
Zunyi
Contact Information
Primary
Erin Lou, Doctor
erinl@hutch-med.com
+86 21 2067 1942
Backup
Yu Wang, Bachelor
yuwang@hutch-med.com
(+86) 18058125909
Time Frame
Start Date: 2024-04-26
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 316
Treatments
Experimental: HMPL-306 arm
HMPL-306
Active_comparator: Salvage treatment arm
Salvage treatment
Related Therapeutic Areas
Sponsors
Leads: Hutchmed

This content was sourced from clinicaltrials.gov

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